Determination That Daranide (Dichlorphenamide) Tablets, 50 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 43645 [E7-15230]
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Federal Register / Vol. 72, No. 150 / Monday, August 6, 2007 / Notices
suppositories, 12.5 mg and 25 mg, were
withdrawn from sale for reasons of
safety or effectiveness.
After considering the citizen petition
and reviewing its records, FDA
determines that, for the reasons outlined
in this notice, PHENERGAN
(promethazine HCl) suppositories, 12.5
mg and 25 mg, were not withdrawn
from sale for reasons of safety or
effectiveness. Accordingly, the agency
will continue to list PHENERGAN
(promethazine HCl) suppositories, 12.5
mg and 25 mg, in the ‘‘Discontinued
Drug Product List’’ section of the Orange
Book. The ‘‘Discontinued Drug Product
List’’ delineates, among other items,
drug products that have been
discontinued from marketing for reasons
other than safety or effectiveness.
ANDAs that refer to PHENERGAN
(promethazine HCl) suppositories, 12.5
mg and 25 mg, may be approved by the
agency as long as they meet all relevant
legal and regulatory requirements for
approval of ANDAs. If FDA determines
that labeling for these drug products
should be revised to meet current
standards, the agency will advise ANDA
applicants to submit such labeling.
Dated: July 30, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7–15174 Filed 8–3–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006P–0160]
Determination That Daranide
(Dichlorphenamide) Tablets, 50
Milligrams, Were Not Withdrawn From
Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
that Daranide (dichlorphenamide)
Tablets, 50 milligrams (mg), were not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for
dichlorphenamide tablets, 50 mg.
FOR FURTHER INFORMATION CONTACT:
Mary Catchings, Center for Drug
Evaluation and Research (HFD–7), Food
and Drug Administration, 5600 Fishers
sroberts on PROD1PC70 with NOTICES
SUMMARY:
VerDate Aug<31>2005
19:38 Aug 03, 2007
Jkt 211001
Lane, Rockville, MD 20857, 301–594–
2041.
In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) (the 1984 amendments), which
authorized the approval of duplicate
versions of drug products approved
under an ANDA procedure. ANDA
sponsors must, with certain exceptions,
show that the drug for which they are
seeking approval contains the same
active ingredient in the same strength
and dosage form as the ‘‘listed drug,’’
which is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA). The only clinical data required
in an ANDA are data to show that the
drug that is the subject of the ANDA is
bioequivalent to the listed drug.
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is generally known as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
agency withdraws or suspends approval
of the drug’s NDA or ANDA for reasons
of safety or effectiveness, or if FDA
determines that the listed drug was
withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
Under 21 CFR 314.161(a)(1), the
agency must determine whether a listed
drug was withdrawn from sale for
reasons of safety or effectiveness before
an ANDA that refers to that listed drug
may be approved. FDA may not approve
an ANDA that does not refer to a listed
drug.
In a citizen petition dated April 12,
2006 (Docket No. 2006P–0160/CP1),
submitted under 21 CFR 10.30, Taro
Research Institute requested that the
agency determine whether Daranide
Tablets, 50 mg, were withdrawn from
sale for reasons of safety or
effectiveness. Daranide
(dichlorphenamide) Tablets, 50 mg, are
the subject of approved NDA 11–366
held by Merck & Co., Inc. (Merck).
Daranide is indicated for adjunctive
treatment of glaucoma. Merck
discontinued marketing Daranide
Tablets, 50 mg, in June 2002, and they
were moved to the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
43645
The agency has determined that
Daranide Tablets, 50 mg, were not
withdrawn from sale for reasons of
safety or effectiveness. The petitioner
identified no data or other information
suggesting that Daranide Tablets, 50 mg,
were withdrawn from sale as a result of
safety or effectiveness concerns. FDA
has independently evaluated relevant
literature and data for possible
postmarketing adverse events and has
found no information that would
indicate that this product was
withdrawn from sale for reasons of
safety or effectiveness.
After considering the citizen petition
and reviewing its records, FDA
determines that, for the reasons outlined
in this notice, Daranide
(dichlorphenamide) Tablets, 50 mg,
were not withdrawn from sale for
reasons of safety or effectiveness.
Accordingly, the agency will continue
to list Daranide (dichlorphenamide)
Tablets, 50 mg, in the ‘‘Discontinued
Drug Product List’’ section of the Orange
Book. The ‘‘Discontinued Drug Product
List’’ delineates, among other items,
drug products that have been
discontinued from marketing for reasons
other than safety or effectiveness.
ANDAs that refer to Daranide
(dichlorphenamide) Tablets, 50 mg, may
be approved by the agency as long as
they comply with relevant legal and
regulatory requirements. If FDA
determines that labeling for this drug
product should be revised to meet
current standards, the agency will
advise ANDA applicants to submit such
labeling.
Dated: July 30, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7–15230 Filed 8–3–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
E:\FR\FM\06AUN1.SGM
06AUN1
]]>Agencies
[Federal Register Volume 72, Number 150 (Monday, August 6, 2007)]
[Notices]
[Page 43645]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-15230]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006P-0160]
Determination That Daranide (Dichlorphenamide) Tablets, 50
Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or
Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined that
Daranide (dichlorphenamide) Tablets, 50 milligrams (mg), were not
withdrawn from sale for reasons of safety or effectiveness. This
determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for dichlorphenamide tablets, 50 mg.
FOR FURTHER INFORMATION CONTACT: Mary Catchings, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-2041.
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Public Law 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products approved under an ANDA procedure. ANDA
sponsors must, with certain exceptions, show that the drug for which
they are seeking approval contains the same active ingredient in the
same strength and dosage form as the ``listed drug,'' which is a
version of the drug that was previously approved. ANDA applicants do
not have to repeat the extensive clinical testing otherwise necessary
to gain approval of a new drug application (NDA). The only clinical
data required in an ANDA are data to show that the drug that is the
subject of the ANDA is bioequivalent to the listed drug.
The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is generally known as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness, or if FDA determines that the
listed drug was withdrawn from sale for reasons of safety or
effectiveness (21 CFR 314.162).
Under 21 CFR 314.161(a)(1), the agency must determine whether a
listed drug was withdrawn from sale for reasons of safety or
effectiveness before an ANDA that refers to that listed drug may be
approved. FDA may not approve an ANDA that does not refer to a listed
drug.
In a citizen petition dated April 12, 2006 (Docket No. 2006P-0160/
CP1), submitted under 21 CFR 10.30, Taro Research Institute requested
that the agency determine whether Daranide Tablets, 50 mg, were
withdrawn from sale for reasons of safety or effectiveness. Daranide
(dichlorphenamide) Tablets, 50 mg, are the subject of approved NDA 11-
366 held by Merck & Co., Inc. (Merck). Daranide is indicated for
adjunctive treatment of glaucoma. Merck discontinued marketing Daranide
Tablets, 50 mg, in June 2002, and they were moved to the ``Discontinued
Drug Product List'' section of the Orange Book.
The agency has determined that Daranide Tablets, 50 mg, were not
withdrawn from sale for reasons of safety or effectiveness. The
petitioner identified no data or other information suggesting that
Daranide Tablets, 50 mg, were withdrawn from sale as a result of safety
or effectiveness concerns. FDA has independently evaluated relevant
literature and data for possible postmarketing adverse events and has
found no information that would indicate that this product was
withdrawn from sale for reasons of safety or effectiveness.
After considering the citizen petition and reviewing its records,
FDA determines that, for the reasons outlined in this notice, Daranide
(dichlorphenamide) Tablets, 50 mg, were not withdrawn from sale for
reasons of safety or effectiveness. Accordingly, the agency will
continue to list Daranide (dichlorphenamide) Tablets, 50 mg, in the
``Discontinued Drug Product List'' section of the Orange Book. The
``Discontinued Drug Product List'' delineates, among other items, drug
products that have been discontinued from marketing for reasons other
than safety or effectiveness. ANDAs that refer to Daranide
(dichlorphenamide) Tablets, 50 mg, may be approved by the agency as
long as they comply with relevant legal and regulatory requirements. If
FDA determines that labeling for this drug product should be revised to
meet current standards, the agency will advise ANDA applicants to
submit such labeling.
Dated: July 30, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-15230 Filed 8-3-07; 8:45 am]
BILLING CODE 4160-01-S
